Low Back PainPhase 3NCT02706054
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
A Phase 3 study testing saline and Meloxicam in people with Low Back Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- saline and Meloxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain from 6 months or less
- older than 18 years
Who cannot join
- not able to understand and sign the written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation
Read the detailed description
In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.
- Conditions
- Low Back Pain
- Being tested
- saline, Meloxicam
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineOther
The patients received an IM injection of saline near the nerve root (periradicular)
MeloxicamDrug
Also called mobic
The patients received an IM injection of meloxicam near the nerve root (periradicular)
| Study group | Role | What they receive |
|---|---|---|
| C-group | Placebo comparator | patients receiving an IM saline injection near the nerve root (periradicular) Receives: Other: saline |
| M-group | Experimental | patients receiving an IM Meloxicam injection near the nerve root (periradicular) Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline NRS pain scale score at different consecutive follow up assessments
Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain)
Measured: 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Secondary outcomes (1)
Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire
pain-related insomnia, physical assistance, sport activities, work absence were assessed using a structured questionnaire with dichotomous items (yes/no presence of impairment to the selected item)
Measured: 5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- battista borghi, MD, Prof, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706054
- Sponsor's protocol ID
- MELO-RCT
- Status last verified
- Jan 2016
- First submitted
- 3 Feb 2016
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Borghi B, Aurini L, White PF, Mordenti A, Lolli F, Borghi R, Martignani M, Greggi T. Long-lasting beneficial effects of periradicular injection of meloxicam for treating chronic low back pain and sciatica. Minerva Anestesiol. 2013 Apr;79(4):370-8. Epub 2013 Jan 10.
PubMed 23306395Aurini L, Borghi B, White PF, TOGNu A, Rossi B, Fini G, Fusco P, Mosca M, Borghi R. Treatment of chronic cervicobrachial pain with periradicular injection of meloxicam. Minerva Anestesiol. 2016 Apr;82(4):411-8. Epub 2015 Sep 3.
PubMed 26337371
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
- ClinicalTrials.gov ID
- NCT02706054
- Acronym / sponsor ID
- MELO-RCT
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation
Detailed description
In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-group | Placebo comparator | Other: salinepatients receiving an IM saline injection near the nerve root (periradicular) |
| M-group | Experimental | Drug: Meloxicampatients receiving an IM Meloxicam injection near the nerve root (periradicular) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low back pain from 6 months or less
- older than 18 years
Key exclusion criteria (1 listed)
- not able to understand and sign the written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salineThe patients received an IM injection of saline near the nerve root (periradicular) | Other | C-group |
| MeloxicamAlso: mobicThe patients received an IM injection of meloxicam near the nerve root (periradicular) | Drug | M-group |
Primary outcome
Change from baseline NRS pain scale score at different consecutive follow up assessments
Time frame: 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain)
1 secondary outcome
Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire
Time frame: 5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 23306395Borghi B, Aurini L, White PF, Mordenti A, Lolli F, Borghi R, Martignani M, Greggi T. Long-lasting beneficial effects of periradicular injection of meloxicam for treating chronic low back pain and sciatica. Minerva Anestesiol. 2013 Apr;79(4):370-8. Epub 2013 Jan 10.
- Background: PubMed 26337371Aurini L, Borghi B, White PF, TOGNu A, Rossi B, Fini G, Fusco P, Mosca M, Borghi R. Treatment of chronic cervicobrachial pain with periradicular injection of meloxicam. Minerva Anestesiol. 2016 Apr;82(4):411-8. Epub 2015 Sep 3.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
battista borghi, MD, Prof principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing saline and Meloxicam in people with Low Back Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline NRS pain scale score at different consecutive follow up assessments (time frame: 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.